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International Study to Predict Optimised Treatment - in Depression (iSPOT-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693849
Recruitment Status : Active, not recruiting
First Posted : June 9, 2008
Last Update Posted : July 11, 2018
Information provided by (Responsible Party):
BRC Operations Pty. Ltd.

Tracking Information
First Submitted Date  ICMJE June 6, 2008
First Posted Date  ICMJE June 9, 2008
Last Update Posted Date July 11, 2018
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00693849 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. [ Time Frame: 52-weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE International Study to Predict Optimised Treatment - in Depression
Official Title  ICMJE International Study to Predict Optimised Treatment - in Depression
Brief Summary The aim of this study is to identify genetic, physical (brain) and psychological (cognitive) markers (or combinations of them) that predict specific response to a range of antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with major depressive disorder. This study is focused on outcomes which may impact on how "personalised medicine" is implemented in depression.
Detailed Description

This is an open-label, randomised (effectiveness) study (ie. comparison of active treatments) to identify genetic markers, brain function, brain structure, and psychological and cognitive indicators (or a combination of markers) in MDD subjects versus healthy controls. Approximately 2,016 subjects with major depressive disorder (MDD) across multiple international sites (USA, Canada, UK, South Africa, New Zealand, The Netherlands and Australia) will be randomised to one of three approved and effective treatment arms:

Treatment A Escitalopram. Treatment B Sertraline. Treatment C Venlafaxine XR.

A group of matched healthy controls (n = 672) will also be enrolled.

Subjects will be asked to attend the testing facility on two separate occasions; for Pre-treatment (Pre-Tx) and at 8 weeks post initiation of treatment. The assessments/procedures at Pre-Tx and Week 8 include: Baseline a clinical work-up, blood collection for genetic analyses, cognitive testing and electrical brain functioning (EEG/ERP). Structural and functional data MRI data will be collected in ten percent (10%) of participants.

On Day 4 and Weeks 2, 4, 6, 12, 16, 24 and 52 Subjects will be contacted by phone and asked to complete 2 questionnaires via the internet.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Escitalopram
    10 mg/day as a single dose, increased to max 20 mg/day
    Other Name: Lexapro
  • Drug: Sertraline
    50 mg/day as a single dose, increased to max of 200 mg/day
    Other Name: Zoloft
  • Drug: Venlafaxine-XR
    75 mg/day given once daily; increased to 150-225 mg/day
    Other Name: Effexor
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Escitalopram
  • Active Comparator: B
    Intervention: Drug: Sertraline
  • Active Comparator: C
    Intervention: Drug: Venlafaxine-XR
  • No Intervention: D
    Healthy matched controls
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2008)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meet DSM-IV criteria for primary diagnosis of MDD.
  • HAM-D17 score of ≥ 16.
  • 18-65 years age-range
  • Subjects with English or Dutch literacy and fluency.
  • Written, informed consent.

Exclusion Criteria:

  • Presence of suicidal ideations and/or tendencies (as determined by a score >12 on Section C, Suicidality, of the MINI Plus), Bipolar I-III, psychosis, primary eating disorders, Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD), Post-Natal Depression as well as any Axis II personality disorders as diagnosed using the MINI Plus or by a health care professional.
  • Pregnancy and women of child bearing potential who are not taking a medically accepted form of contraception and are at risk of becoming pregnant during the study.
  • Breastfeeding.
  • Known contra-indication or intolerance to the use of Escitalopram, Sertraline or Venlafaxine XR as defined in the product package insert for each drug (including previous treatment failure at the highest recommended dose).
  • Use of any psychological or counselling therapy or antidepressant/CNS drug which cannot be washed out prior to participation and eliminated until after Week 8 or discontinuation.
  • Use of any medication which is known to be contraindicated with Escitalopram, Sertraline, or Venlafaxine XR (refer to the product package insert for each drug).
  • Known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put subjects at increased risk when exposed to optimal doses of the drug treatment.
  • History of head injury with loss of consciousness for at least 10 minutes.
  • Recent/current substance dependence (as defined in Section K of the Mini Plus as per a 6 months period and/or alcoholism) in the past six months.
  • Participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study.
  • Subjects who, in the opinion of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere with their ability to complete the test batteries.
  • Subjects who, in the opinion of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Netherlands,   New Zealand,   South Africa,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00693849
Other Study ID Numbers  ICMJE iSPOT-D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BRC Operations Pty. Ltd.
Study Sponsor  ICMJE BRC Operations Pty. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony Harris, MD Brain Dynamics Centre
Principal Investigator: Barbara A. Cohen, PhD Center for Healing the Human Spirit
Principal Investigator: Bruce Russell, PhD University of Auckland, New Zealand
Principal Investigator: Charles Debattista, MD Stanford University
Principal Investigator: Con Stough, PhD Swinburne University
Principal Investigator: Elizabeth Wallis, PhD Brain Health Lab
Principal Investigator: Harbans Multani, MD Shanti Clinical Trials
Principal Investigator: Jayashri Kulkarni, Prof The Alfred and Delmont Private Hospital
Principal Investigator: Jeffrey Wilson, PhD A.D.D. Treatment Center
Principal Investigator: Kamran Fallahpour, PhD Brain Resource Center
Principal Investigator: Larry Hirshberg, PhD NeuroDevelopment Center
Principal Investigator: Martijn Arns, PhD Brainclinics Diagnostics B.V.
Principal Investigator: Mona Ismail, MD Brain Resource Center
Principal Investigator: Paul Fitzgerald, PhD The Alfred
Principal Investigator: Richard Clark, PhD Flinders University
Principal Investigator: Roger deBeus, PhD Skyland Behavioral Health Associates
Principal Investigator: Steven Bruce, PhD University of Missouri, St. Louis
Principal Investigator: Subhdeep Virk, MD Ohio State University
Principal Investigator: Tim Usherwood, MD Brain Dynamics Centre
Principal Investigator: XiaoLei Yu Baran, MD Cornell University
Principal Investigator: Radu V Saveanu, MD University of Miami
PRS Account BRC Operations Pty. Ltd.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP